Quality Engineer

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Engineer to join our New Richmond, Wisconsin location. What You Will Do: Lead quality assurance activities for new product introduction (NPI) projects to ensure compliance with regulatory requirements (FDA, GMP, ISO 13485, etc.). Develop and maintain quality plans for new medical device product introductions. Perform audits and inspections of NPI processes to ensure adherence to internal and external quality standards. Manage and oversee quality documentation, including specifications, validation reports, and product dossiers. Support regulatory submissions by compiling and reviewing quality-related documentation. Monitor product performance during initial production runs to identify opportunities for improvement. Facilitate training and knowledge sharing across teams regarding quality expectations and best practices. Stay informed of industry trends and regulatory updates to ensure compliance and competitiveness. Lead risk management activities including Design FMEA, Process FMEA, and Control Plans. Collaborate with suppliers on quality requirements and audits to ensure component and material quality. Facilitate root cause investigations and corrective actions for quality issues during product launch. Conduct quality reviews and ensure alignment with internal standards and external regulatory bodies. Assist with documentation and audit readiness for FDA inspections and ISO 13485 certification. Drive continuous improvement efforts to enhance product quality and manufacturing processes. Who you are (Basic Qualifications): Bachelor’s degree in engineering, Quality, Life Sciences, or related field. Experience with FDA QSR, ISO 13485, and medical device regulatory environment. Strong knowledge of quality tools such as SPC, FMEA, 8D, CAPA. Excellent problem‑solving skills and ability to work cross‑functionally. Experience with product validation, verification, and risk management in medical devices. Legal authorization to work permanently in the United States for any employer without requiring a visa transfer or visa sponsorship. This role is not eligible for VISA sponsorship. Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E‑Verify. #J-18808-Ljbffr Phillips Medisize